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This is a single-center, open-label, dose-escalating study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of single and multiple subcutaneous injection TK006 in patients with breast cancer-related bone metastases.
Full description
This is an single-center, open-label, dose-escalating study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of single and multiple subcutaneous injection TK006 in patients with breast cancer-related bone metastases. It contains 4 cohorts:60 mg single-dose conhort, 120 mg single-dose conhort, 180 mg single-dose conhort and 120 mg Q4W (one dose every 4 weeks, 3 dose totally) conhort.
Enrollment
Sex
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Volunteers
Inclusion criteria
Patients provide written informed consent voluntarily;
18~65 years old;
Patients with pathology confirmed breast cancer radiological evidence with bone metastasis;
Eastern Cooperative Oncology Group(ECOG) performance status≤2
Anticipated life span≥6-month;
Adequate reservation of hematopoiesis, liver and kidney functions:
Albumin-adjusted calcium≥2.0 mmol/L, ≤2.9 mmol/ L(Calcium supplements are not allowed within 8 hours before examination).
Exclusion criteria
Previous or existing osteomyelitis or osteonecrosis of jaw, odontia or jaw diseases which are in active or require invasive operations, unhealing wound of oral surgery, or planned invasive dental operations during this trial.
Has been selected for the study of other test devices or test drugs, or the duration of the clinical studies that have taken less than 30 days or 5 half-lives or biological effects, whichever is longer.
Other situations which are not suitable for participation judged by the principal investigator (PI).
Primary purpose
Allocation
Interventional model
Masking
40 participants in 4 patient groups
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Central trial contact
Jiang H B; Yu M X
Data sourced from clinicaltrials.gov
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